Uses
Insomnia
Conventional tablets used for short-term management of insomnia characterized by difficulties with sleep initiation. Decreases sleep latency in patients with chronic or transient insomnia; no substantial evidence of diminished effectiveness during the end of each night’s use (early morning insomnia) despite short half-life.
Extended-release tablets used for management of insomnia characterized by difficulty with sleep onset or sleep maintenance.
Dosage and Administration
General
- Use only when able to get 7–8 hours of sleep before being active again.
- Reevaluate patient if zolpidem is to be used for more than 2–3 weeks. (See Adequate Patient Evaluation under Cautions.)
- Avoid abrupt discontinuance after prolonged (e.g., longer than 1–2 weeks) therapy; consider gradual dosage reduction (e.g., over several nights) when discontinuing short-term therapy.
Administration
Oral Administration
Administer immediately before going to bed when ready to go to sleep.
Onset of sleep may be facilitated by taking the drug on an empty stomach. Do not administer extended-release tablets with or immediately after a meal. (See Food under Pharmacokinetics.)
Swallow extended-release tablets whole; do not divide, crush, or chew.
Dosage
Available as zolpidem tartrate; dosage is expressed in terms of the salt.
Individualize dosage; use smallest effective dose.
Adults
Insomnia
Oral
10 mg (as conventional tablets) or 12.5 mg (as extended-release tablets).
Prescribing Limits
Adults
Insomnia
Oral
Maximum 10 mg daily as conventional tablets. Higher doses (e.g., 15 or 20 mg) occasionally have been used but may be associated with increased risk of adverse effects, including abuse potential.
Special Populations
Dosage in Hepatic Impairment
Prolonged elimination. Initially, 5 mg (as conventional tablets) or 6.25 mg (as extended-release tablets).
Dosage in Renal Impairment
Possible pharmacokinetic alterations. (see Elimination: Special Populations, under Pharmacokinetics.) Manufacturer recommends close monitoring but states that dosage reduction is not necessary; some clinicians recommend that dosage reduction be considered.
Geriatric or Debilitated Patients
Possible increased sensitivity to sedatives and hypnotics. Initially, 5 mg (as conventional tablets) or 6.25 mg (as extended-release tablets). (See Geriatric Use under Cautions.)
Cautions
Contraindications
Warnings/Precautions
Warnings
Adequate Patient Evaluation
Insomnia may be a manifestation of an underlying physical and/or psychiatric disorder; carefully evaluate patient before providing symptomatic treatment.
Failure of insomnia to remit after 7–10 days of treatment, worsening of insomnia, or emergence of new abnormal thinking or behavior may indicate the presence of an underlying psychiatric and/or medical condition that requires evaluation.
Adverse Psychiatric Events
Abnormal thinking and behavioral changes (e.g., aggressiveness, uncharacteristic extroversion, bizarre behavior, agitation, hallucinations, depersonalization, amnesia) may occur unpredictably. Possible worsening of depression (including suicidal thinking) with sedative or hypnotic use in patients with depression. Immediately evaluate any new behavioral sign or symptom.
Some adverse effects appear to be dose related; use the lowest effective dose.
Complex Sleep-related Behaviors
Complex behaviors such as sleep-driving (i.e., driving while not fully awake after ingesting a sedative and hypnotic drug, with no memory of the event), preparing and eating food, making phone calls, or having sex while not fully awake after taking a sedative and hypnotic drug, and usually with no memory of the event, reported.
May occur in sedative and hypnotic drug-naive or drug-experienced patients.
Increased risk with concomitant use of alcohol and other CNS depressants or use of the drug at dosages exceeding the maximum recommended dosage; however, may occur with the drug alone at therapeutic dosages.
Consider discontinuing drug in patients who report a sleep-driving episode because of the risk to the patient and community.
Withdrawal Effects
Rapid dosage reduction or abrupt discontinuance of sedatives or hypnotics has resulted in signs and symptoms of withdrawal.
Abuse Potential
Abuse potential similar to that of benzodiazepines and related hypnotics.
Patients with a history of drug or alcohol dependence or abuse are at risk of habituation or dependence; use only with careful surveillance in such patients.
CNS Effects
Rapid onset of CNS effects (sedation, impairment of psychomotor function, impairment of short-term memory); administer only immediately before going to bed.
Performance of activities requiring mental alertness or physical coordination may be impaired the day after ingestion. Some reports of decreased psychomotor and mental performance in adults and geriatric individuals; other studies found no evidence of residual daytime sedative effects. Risk of residual daytime sedation and impaired performance appears to be minimal at usual dosages.
Concurrent use of other CNS depressants may cause additive or potentiated CNS depression. (See Specific Drugs under Interactions.)
Sensitivity Reactions
Angioedema involving the tongue, glottis, or larynx reported rarely following initial or subsequent doses of sedative and hypnotic drugs, including zolpidem. Some patients experienced additional symptoms (e.g., dyspnea, closing of the throat, nausea and vomiting [suggestive of anaphylaxis]). Some individuals required medical treatment in an emergency department. Angioedema reported during postmarketing surveillance.
Airway obstruction may occur if angioedema involves the throat, glottis, or larynx and can be fatal.
Do not rechallenge with the drug if angioedema occurs.
Advise patients to immediately discontinue the drug and inform their clinician if signs of an allergic reaction (e.g., rash, hives, dyspnea, swelling of tongue or throat) occur.
General Precautions
Respiratory Effects
No respiratory depressant effects reported at hypnotic doses in healthy individuals or in patients with mild to moderate COPD; however, decreased oxygen saturation reported in patients with mild to moderate sleep apnea. Respiratory insufficiency reported, mostly in patients with preexisting respiratory impairment.
Use with caution in patients with compromised respiratory function.
Suicide
Use with caution in depressed patients. Potential for suicidal tendencies; overdosage more frequent in such patients. Prescribe and dispense drug in the smallest feasible quantity.
Concurrent Diseases
Limited experience in patients with concurrent systemic disease. Use with caution in patients with diseases affecting metabolism or hemodynamic response. Use zolpidem tartrate extended-release tablets with caution in patients with sleep apnea syndrome or myasthenia gravis.
Specific Populations
Pregnancy
Category C.
Lactation
Distributed into milk in small amounts; potential effects on nursing infants are not known. Use is not recommended.
Pediatric Use
Safety and efficacy of zolpidem tartrate conventional tablets not established in children. Dizziness, headache, and hallucinations reported.
Safety and efficacy of zolpidem tartrate extended-release tablets not established in children <18 years of age.
Geriatric Use
Pharmacokinetic changes in geriatric patients compared with younger adults. (See Absorption and also Elimination, under Pharmacokinetics.)
Potential increased sensitivity to sedatives and hypnotics. Adverse effects tend to be dose related, particularly in geriatric patients. Adverse effect profile in patients ≥65 years of age receiving 6.25-mg dose (as extended-release tablets) similar to that in younger adults receiving 12.5-mg dose.
Use low initial dose and monitor closely. (See Geriatric or Debilitated Patients under Dosage and Administration.)
Hepatic Impairment
Prolonged elimination; reduce initial dose and monitor closely. (See Hepatic Impairment under Dosage and Administration.)
Renal Impairment
Possible pharmacokinetic alterations. (See Elimination: Special Populations, under Pharmacokinetics.) Monitor closely. Some clinicians recommend dosage reduction (see Renal Impairment under Dosage and Administration.)
Common Adverse Effects
With short-term use at recommended dosages: drowsiness or somnolence, dizziness, headache, diarrhea.
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